BEUDAMED
    FDA Adverse Event Injury Summary report: N

    635 NANOMETER LIGHT (NHN)

    MDR report key: 1736530 · Received June 23, 2010

    Report

    Report Number
    MW5016476
    Event Type
    Injury
    Date Received
    June 23, 2010
    Date of Event
    April 28, 2010
    Report Date
    June 23, 2010
    Manufacturer
    ERCHONIA (ERCHMEDIC)
    Product Code
    NHN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LIGHT THERAPY ON FACE FOR TRIGEMINAL NEURALGIA. TREATMENT CAUSED NAUSEA, SWEATS, SHAKING, PATIENT UNABLE TO DRIVE AND ALMOST PASSING OUT. PATIENT HAS HAD FOUR EPISODES SINCE TREATMENT. NOW SEEING NEUROLOGIST AND CARDIOLOGIST FOR CAUSE. PATIENT WOULD LIKE TO KNOW IF GOGGLES SHOULD HAVE BEEN WORN DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 635 NANOMETER LIGHT (NHN) NHN ERCHONIA (ERCHMEDIC)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other